Cleared Traditional

OEC One ASD

K240828 · Ge Hualun Medical Systems Co. , Ltd. · Radiology

Dec 2024

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K240828 is an FDA 510(k) clearance for the OEC One ASD, a Image-intensified Fluoroscopic X-ray System, Mobile (Class II — Special Controls, product code OXO), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 27, 2024, 276 days after receiving the submission on March 26, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K240828 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2024
Decision Date	December 27, 2024
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OXO — Image-intensified Fluoroscopic X-ray System, Mobile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Fluoroscopy Of The Human Body.